View
1
Download
0
Category
Preview:
Citation preview
Containment Barrier Isolator (CBI)
PLATFORMSPECIALIST.
• PassChambercomesin2sizes:
-Small,non-gloved
-Large,non-gloved/gloved
Applications• PharmacyCompounding(Chemotherapy/TPN)
• AsaClassIIICabinetforBiosafetyLevels(BSL)3and4
• SmallBatchSterilityTesting
• Small-scalePotentMaterialHandling
• CellProcessing
• AsepticProcessing
• ResearchandDevelopment
Key Features• Controlsexposure/cross-contaminationrisktohazardous/aseptic
materialsforawidevarietyofequipmentandprocesses
• Controlsfalse-positiveriskforsterilitytesting
• ProvidesOperatorExposureLevels(OEL’s)≤1.0μg/m3during
controlledoperations
• Levelsof≤0.1μg/m3canbeachievedviaclosed-transferprocesses
orbasedonclientSOPs
• EnhancescGMPpractices
• Quiet,energy-efficientECMfansautoadjusttocompensatefor
filterblockage
• Standarddimensionsavailableareeasilycustomizedtosuitprocess
requirements
• Safeglovechangeandlowcontaminationfilterchange
• FDA-approvedstaticseals
• Pressuretestedclass1ISO10648-2standards
• SystemcomeswithaSemi-automatedorAutomatedPressureHold
Testing
WarrantyOneyearwarranty(excludingconsumables).Consumablesareballast,fluorescent,andfilters.Thewarrantywillcoverallotherpartsincludingtheblower, fan switch, and electricalmain board.During theperiodof warranty, any repair, modification, testing and commissioningperformedbyanyunathorizedpartyotherthanEscoServiceTeamwillvoidthewarrantyoftheunit.
Introduction
Containment BarrierIsolator (CBI)
Filtration PackageProcess Chamber• RoomInletFilter–F6filtration.Panelfilter,glassfibermedia.• Chamber Inlet Filter – SingleU15ULPAfiltration. Panel filter, gel
seal,glassfibermedia.• Chamber Return Filter – Single H14 HEPA filtration. Panel filter,
gasketseal,glassfibermedia.• ChamberOutletFilter–StandardF6filtration,optionalH14HEPA
filtration.Panelfilter,gasketseal,glassfibermedia.
Note: Hydrogen Peroxide Vapor (HPV) will pass through the filters during the HPV cycle to allow decontamination of the filters and air path.
Pass Chamber• RoomInletFilter–G4filtration.Panelfilter,polyestermedia.• ChamberInletFilter–SingleU15ULPAfiltration.Panelfilter,gasketseal,glassfibermedia.• ChamberExhaustFilter–F6filtration.Panelfilter,gelseal,glassfibermedia.
Note: HPV will pass through the HEPA filters during the HPV cycle to allow decontamination of the filters and air path.
Basic Principles
• Equipped with dual SentinelTM Platinum Microprocessor ControlSystem
• StandardControlssuitableforsafeareaapplications• IncludestwoIP66electricalsocketsasstandard
Esco Containment Barrier Isolator (CBI) facilitates the isolation of aproductorprocesswhileprovidingtherequiredconditionsforasterile/asepticenvironment. It isconfiguredtooperateatpositiveornegativepressure.Thisequipmentprovidesacomprehensiverangeofpersonneland product protection in addition to protection for the surroundingworkareasandtheenvironment.
CBI'sdesignhascompletecompliancetoPIC/sandEUcGMPstandardswithits19mmradiuscovedinternalcornersinasinglepiecechamber(noperforationsorgrillesforcontaminantstobetrappedonall4corners).ItsRearReturnFilterensures thatductsarenotcontaminated.Thesystemcomesineitherrecirculatoryorsinglepassairflow.
ENGINEERING DRAWING
770mm(3
0.3"
)
841mm(3
3.1"
)
553mm(21.8")
627mm(24.7")
920mm(36.2")
916
917
918
919
915
914
913
912
615mm(24.2")
660mm(2
6.0"
-M
in)
960mm(3
7.8"
-M
ax)
1200mm(47.2")
1600
mm(6
3.0"
)
1815mm(71.5")
2560
mm(1
00.8"-Max)
2260
mm(8
9.0"
-M
in)
91
92
93
94
97
96
98
99
910
911
95
7. Sliding Tray 8. Main Control Panel 9. Foot Switch10. Leveling Feet11. Caster Wheel12. F6 Pre-filter13. Inlet EC Centrifugal Fan
14. Exhaust EC Centrifugal Fan
15. Gel-Sealed U15 Inlet Filter
16. T5 Fluorescent Lamp
17. Magnetic Interlock
18. Gasket-Sealed H14 Return Filter
19. Hydraulic Adjustable Support Stand (Optional)
1. Dampers
2. Emergency Stop or E-Stop
3. Pressure Injection Buttons
4. SentinelTM Platinum Microprocessor Control System
5. Pass Chambers
6. Process Chamber
CBI-2G CBI-3G CBI-4G
Main Chamber Nominal Size (Width) 1.2m 1.6m 2.0m
Working Chamber Dimensions - Min (L x W x H) 1.2mx0.55mx0.77m 1.6mx0.55mx0.77m 2.0mx0.55mx0.77m
Working Chamber Dimensions - Max (L x W x H) 1.2mx0.63mx0.84m 1.6mx0.63mx0.84m 2.0mx0.63mx0.84m
External Dimension(with one Pass Chamber) (L x W x H)
WithAdjustableBaseStand(Min) 1.82mx0.92mx2.26m 2.22mx0.92mx2.26m 2.62mx0.92mx2.26m
WithAdjustableBaseStand(Max) 1.82mx0.92mx2.56m 2.22mx0.92mx2.56m 2.62mx0.92mx2.56m
Glove Port Height (Min) 1000mm 1000mm 1000mm
Glove Port Height (Max) 1300mm 1300mm 1300mm
Chamber Environment ISOClass5allChambers(GradeA)
Filter Type - Chamber Inlet ULPAU15withIntegralMeshGuardandKnifeEdgeGelSeal
Filter Efficiency - Chamber Inlet 99.9998%
Filter Type - Chamber Exhaust HEPAH14withIntegralMeshGuardandGasketSeal
Filter Efficiency - Chamber Exhaust 99.995%
Lighting Level ≥700Lux
Sound Level <63dBA TBA TBA
Isolator Construction
Chamber SS316L
ServiceHousing SS304L
SupportFrame SS304L
Isolator Finish
ChamberInternal ≤0.4Ra
ChamberExternal ≤0.6Ra
ServiceHousingExternal ≤0.6Ra
SupportFrame ≤1.0Ra
Electrical Requirements (by Client)
220-240VAC,50/60Hz,1Ø
110-120VAC,50/60Hz,1Ø
Compressed Air Requirement (by Client)if no on-boardcompressor
2Bar-gPressureat5L/sec
Exhaust Duct Requirements (by Client)unless Integral Catalytic Convertor is Included
10"DuctfromIsolatortoOutside
Options
PassChamber(Small,nonglovedorLarge,nongloved/gloved)
Bio-DecontaminationBIOVAP
Non-ViableAirSampler
ViableAirSampler
SterilityTestPump
GloveTester
WasteBagGrommet
SterileContinuousLiner
BagWelderwithTable
RTPØ105,190,270,350,460-Alpha
RTPØ105,190,270,350,460-BetaCanister
RTPØ105,190,270,350,460-BetaLiner
AnalyticalBalance
SprayGun
TemperatureandHumidityMonitor
H2O2Monitoring
ProductWasteEntry/ExitPorts
LiquidWasteEntry/ExitPorts
4"ButterflyValve
Drain
LinerSystem
On-boardAirCompressor
UVLamp
CarbonFilter
AdjustableHydraulicStand
CCTVCamera
TVMonitor
GENERAL SPECIFICATIONSCONTAINMENTBARRIERISOLATOR(CBI)
Con
tain
men
t_Ba
rrie
r_Is
olat
or_S
ellsh
eet_
vB_A
4_v4
_140
415
Esco
can
acc
ept n
o re
spon
sibili
ty fo
r pos
sible
err
ors i
n ca
talo
gues
, bro
chur
es a
nd o
ther
pri
nted
mat
eria
ls. E
sco
rese
rves
the
righ
t to
alte
r its
pro
duct
s and
spec
ifica
tions
with
out n
otic
e. A
ll tr
adem
arks
and
logo
type
s in
this
mat
eria
l ar
e the
pro
pert
y of
Esc
o an
d th
e res
pect
ive c
ompa
nies
. Spe
cific
atio
ns in
clude
d in
this
sell
shee
t are
subj
ect t
o ch
ange
w
ithou
t prio
r not
ice.
LIVE SUPPORTescoglobal.com
PT Esco Bintan IndonesiaCert. No: 651333/E
Esco Micro Pte Ltd Cert. No: 651076
PT Esco Bintan IndonesiaCert. No: Q2N130383797001
Esco Pharma dedicated R&D engineers have a combined 30 years of experience in systems design of a variety of containment and aseptic process equipment. Compared to industry averages, Esco invests a significant percentage of annual revenues in research and development. As a result of our investment, and with continuous feedback and idea evaluation among our research, global sales, marketing, purchasing and manufacturing teams, Esco products reflect the best contemporary designs in performance, ergonomics and customer satisfaction. www.escopharma.com
Sales/Service Subsidiary CompaniesFactory
PLATFORMSPECIALIST.
Esco Pharma Pte Ltd21 Changi South Street 1 Singapore 486777 • Tel: +65 65420833Fax: +65 65426920 • Email: csis.pharma@escoglobal.com
Esco Technologies, Inc.1661 Loretta Ave., Feasterville, PA 19053Tel: 215 322 2155 • Email: eti.pharma@escoglobal.com
Esco Gb LtdUnit 9, Century Park Networkcentre, Dearne Lane,Manvers, Rotherham, South Yorkshire, S63 5DE.Tel: +44 (0) 1709 761 669 • Email: egb.info@escoglobal.com
Esco Global Offices: Sydney, Australia | Manama, Bahrain | Beijing, China | Chengdu, China | Guangzhou, China | Shanghai, China
Kowloon, Hong Kong | Bangalore, India | Delhi, India | Mumbai, India | Jakarta, Indonesia | Rome, Italy | Osaka, Japan
Kuala Lumpur, Malaysia | Melaka, Malaysia | Manila, Philippines | Moscow, Russia | Singapore | Midrand, South Africa
Seoul, South Korea | Bangkok, Thailand | Barnsley, United Kingdom | South Yorkshire, United Kingdom | Philadelphia, PA, USA | Hanoi, Vietnam
Pharma Equipment Product Range
Air ShowerAseptic Containment Isolator (ACTI)Ceiling Laminar Airflow UnitsContainment Barrier Isolator (CBI)Dynamic Pass BoxEsco Straddle Unit SingleEvidence Drying CabinetGarment Storage CabinetGeneral Processing Platform Isolator (GPPI)Hard CapsuleLaminar Flow Horizontal TrolleyLaminar Flow Straddle UnitsLaminar Flow Vertical TrolleyPass BoxSoft CapsuleSputum BoothWeighing and Dispensing Containment Isolator (WDCI)
ESCO GlObal NEtwOrk
Recommended